Current report No. 3/2023 – Information regarding the Company’s meeting with the Food and Drug Administration (FDA) under the End of Phase II (EOP2) meeting procedure for Celon’s esketamine DPI (Falkieri) project
Date: February 24, 2023, 10:44 AM
Legal basis: Article 17 of the Market Abuse Regulation (MAR) – inside information.
The Management Board of Celon Pharma S.A. (“Company”) hereby informs that on February 23, 2023, the so-called End of Phase II meeting took place. The participants included, among others, the Division of Psychiatry at the Food and Drug Administration (FDA). The purpose of the meeting was obtaining the FDA’s opinion regarding the project of the phase-III clinical program proposed by the Company for esketamine DPI (Falkieri), in the indication of treatment-resistant bipolar depression.
As a result of the meeting the Company achieved the assumed strategic aims regarding the anticipated form of the clinical program and was granted the opportunity of conducting a phase-III clinical program in the US in the discussed form. The planned research will consist of two short-term studies and one long-term study, in line with the adopted plan.
Moreover, the Company received confirmation for the adopted definitions which will be vital for the correct and simultaneously efficient enrolment of patients with treatment-resistant bipolar depression into the clinical program.
The Management Board is of the opinion that the course of the meeting as well as its substantive conclusions are positive. The obtained opinion constitutes an important element of limiting the risk of failure to register the drug for the developed Falkieri product, as well as an important step in the development process of the drug.